CN1332672C - Arsenic trioxide powder for injection - Google Patents
Arsenic trioxide powder for injection Download PDFInfo
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- CN1332672C CN1332672C CNB011041110A CN01104111A CN1332672C CN 1332672 C CN1332672 C CN 1332672C CN B011041110 A CNB011041110 A CN B011041110A CN 01104111 A CN01104111 A CN 01104111A CN 1332672 C CN1332672 C CN 1332672C
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- arsenic trioxide
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- trioxide powder
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The present invention discloses arsenic trioxide injection powder which comprises analytically pure arsenic trioxide powder and sodium hydroxide as a solvent thereof, both processed by sterilizing, dissolving, filtering and sterilizing again. The injection powder has the advantages of simple production equipment and process sequence, low cost, accurate medicine content, etc., can avoid arsenic trioxide damage on production people and can not generate arsenic-containing waste or waste water polluting the environment. The injection powder is suitable for treating tumors such as leukemia, oesophagus cancers, multiple myeloma, malignant lymphoma, etc. and intractable diseases such as malaria, syphilis, rheumatic diseases, etc.
Description
The present invention relates to the medicine preparation field, particularly a kind of arsenic trioxide powder for injection.
Arsenicum, medicinal from ancient times, all on the books at Chinese herbal medicine document Compendium of Material Medica at all times, " poisonous Chinese herbal medicine voluminous dictionary) " etc.The chemical analysis of arsenicum is an arsenic trioxide, and arsenic once was used as " analeptic " or " analeptic " in ancient times.Modern study shows that a small amount of arsenic (lethal dose is 70-180mg/ time) for oral administration can promote the synthetic of protein in body, stimulate bone marrow hematogenesis, help body growth and breeding, and may pass through protoplasmic poison kill tumor cell (" poisonous Chinese herbal medicine voluminous dictionary " Tianjin, Guo Xiao village Scientific English Translation publishing house 1992).The clinical research (1992-1998) that I preside over shows: arsenic trioxide all has significant curative effect to acute promyelocytic leukemia (APL) that just control, recurrence and refractory, its complete remission rate (CR) is respectively 87.9%, 88.4% and 48.7%, 5 years with seven probabilities of living in a year reach 90% and 70% (on " Chinese Journal of Hematology " 2000,2, report being arranged) respectively.The APL that five medical research units such as Rui Jin, Shanghai hospital recur with the arsenic trioxide treatment, complete remission rate is 91.07% (51/56).Clinical and experimentation shows that arsenic trioxide has differentiation of inducing, apoptosis-induced and kill, suppress comprehensive functions such as propagation to the APL cell.In vitro study shows that arsenic trioxide all has effect apoptosis-induced or inhibition propagation to many cell strains such as myelocytic series leukemia and lymphocytic tumors.In addition, arsenic trioxide is to squamous cell carcinoma of esophagus Ec8712 cell line, child's neuroblastoma cell system (SJ-N-SH), cancer of pancreas SW1990, nude mice SRC cancer of pancreas metastatic carcinoma, people's hepatocarcinoma SMMC-7721 and HopGZ101 cell line, rat liver cancer, murine sarcoma S180, breast carcinoma MDA-MB-468 and T47D cell line, human lung adenocarcinoma GLC-82, colon cancer LoVo cell line, solid tumors such as gastric cancer MKN-45, MKN-28 and human cervical carcinoma Hela cell system all have its growth or the effect such as apoptosis-induced of suppressing.In recent years, primary hepatocarcinoma, cancer of biliary duct hepatic metastases, malaria, a rheumatoid arthritis example are used the arsenic trioxide treatment and are all obtained obvious curative effects.
I reach clinical observation and the many bibliographical informations in 7 years, and pharmacokinetic shows that all the arsenic trioxide toxicity is light, use safer, less bone marrow depression and the peripheral hemogram (mainly being leukocyte) descend (6.15%) of occurring.More common untoward reaction has: 1, loss of appetite, abdominal distention or abdominal discomfort, feel sick, vomiting and diarrhoea etc.; 2, xerosis cutis, pigmentation or erythema; 3, liver function MC (transaminase and bilirubin rising etc.); 4, other: joint or muscular soreness, edema, headache, blood urea nitrogen raise or slight electrocardiographic abnormality etc. all rare.
Because arsenic trioxide is higher to the some diseases curative effect, have distinctive feature for cancer and some pertinacious diseases especially, thereby receive the very big concern of the parties concerned, and the positive tissue scientific research strength is researched and developed.The successful Related product of existing research and development is used for clinical, as: application number is 95108768.1, and denomination of invention is the patent application of " " Ailing " anticancer injection ".Its name of product is arsenous acid injection (Arsenic Acid Injection, the accurate word X19990191 of traditional Chinese medicines), by arsenic trioxide, NaCl and water for injection, make through technologies such as high temperature heating, solubilising, filtration, sterilizations, the product design scope is 0.95g/L-10.5g/L (every 10ml content is 9.5mg-10.5mg).Injection formulation is complex manufacturing not only, the production cost height, and in process of production,, thereby to be subjected to the infringement of arsenic inevitably owing to the staff wants frequently contact with arsenic.Also produce more arsenic waste product and the arsenic-containing waste water of containing in addition in process of production, can pollute to environment.For not making its contaminated environment, must handle, from and further strengthened production cost.
It is identical to the purpose of this invention is to provide a kind of drug effect, and production technology is simple, arsenic trioxide novel formulation free from environmental pollution.
Purpose of the present invention can reach by the following technical programs: this scheme provides a kind of arsenic trioxide powder for injection.It comprises arsenic trioxide powder and solvent sodium hydroxide two parts, respectively through sterilizing and dissolving, filter, sterilize and make.The arsenic trioxide powder can be by market purchasing, and product specification has three kinds of 2mg, 5mg and 10mg.The concentration range of solvent sodium hydroxide solution is 0.3118-0.8488mol/L, and specification has three kinds of 0.4ml, 1ml and 2ml.The proportioning of arsenic trioxide powder and solvent sodium hydroxide solution is: 1mg: 0.2ml.
The present invention has production equipment and process is simple, and is with low cost, and its medicament contg is accurate, can avoid the infringement of arsenic trioxide to producers aborning, and can not produce contaminated environment contain arsenic waste product and arsenic-containing waste water.
The present invention is applicable to tumors such as treatment leukemia, the esophageal carcinoma, multiple myeloma, malignant lymphoma, and pertinacious diseases such as malaria, syphilis, rheumatism.Adult 10mg every day or press body surface area 6mg/m2 and measure, the child can be cut down according to the circumstance by body surface area.
Embodiment 1
Get the arsenic trioxide powder 10mg of analytical pure through sterilization, the sterilization lyase NaOH solution 2ml that adds preparation makes dissolving, then, it is added in 0.9% sodium chloride or 5% glucose solution of 500ml, is used for intravenous drip.
Embodiment 2
Get the arsenic trioxide powder 5mg of analytical pure through sterilization, the sterilization lyase NaOH solution 1ml that adds preparation makes dissolving, then, it is added in 25,0m1 0.9% sodium chloride or 5% glucose solution, is used for intravenous drip.
Embodiment 3
Get the arsenic trioxide powder 2mg of analytical pure through the mattress that goes out, the sterilization lyase NaOH solution 0.4ml that adds preparation makes dissolving, then, it is added in 100ml or 250ml 0.9% sodium chloride or 5% glucose solution, is used for intravenous drip.
Because arsenical has certain toxicity to nervous system and liver, therefore with serious liver or neurological conditions or contact arsenic for a long time the person should be forbidden, careful usefulness or decrement use; Unsuitable for children is done choice drug treatment or life-time service.
Claims (3)
1, a kind of arsenic trioxide powder for injection, comprise arsenic trioxide powder and solvent sodium hydroxide solution two parts, it is characterized in that: described arsenic trioxide powder part is formed through sterilization by commercially available arsenic trioxide powder, and solvent sodium hydroxide solution part is made through dissolving, filtration, sterilization by sodium hydroxide.
2, powder for injection according to claim 1 is characterized in that: arsenic trioxide powder and the two-part proportioning of solvent sodium hydroxide solution are 1mg: 0.2ml.
3, powder for injection according to claim 1 and 2 is characterized in that: the concentration of solvent sodium hydroxide solution is: 0.3118-0.8488mol/L.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011041110A CN1332672C (en) | 2001-03-15 | 2001-03-15 | Arsenic trioxide powder for injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011041110A CN1332672C (en) | 2001-03-15 | 2001-03-15 | Arsenic trioxide powder for injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1375294A CN1375294A (en) | 2002-10-23 |
| CN1332672C true CN1332672C (en) | 2007-08-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011041110A Expired - Fee Related CN1332672C (en) | 2001-03-15 | 2001-03-15 | Arsenic trioxide powder for injection |
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| CN (1) | CN1332672C (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142648B (en) * | 2011-12-07 | 2015-04-15 | 浙江中医药大学 | Arsenic compound solution, and alhumin nanoparticles encapsulated with arsenic compound and freeze-drying preparation prepared by same |
| CN103099816B (en) * | 2013-02-04 | 2014-09-03 | 浙江大学 | Drug composition inducing mitochondrial apoptosis of multiple myeloma cells |
| CN103655613A (en) * | 2013-02-08 | 2014-03-26 | 复旦大学附属肿瘤医院 | Application of arsenic trioxide and water-soluble object thereof in preparing medicine for treating pancreatic cancer |
| CN104274489B (en) * | 2013-06-05 | 2017-04-12 | 楼兰花 | Combined medicine for treating tumors |
| CN110101713A (en) * | 2019-05-16 | 2019-08-09 | 上海交通大学医学院附属第九人民医院 | A kind of application of arsenic trioxide composition |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285743A (en) * | 1997-11-10 | 2001-02-28 | 斯隆－凯特林纪念癌症中心 | Process for production of arsenic trioxide formulations and methods for treating cancer using arsenic troxide or melarsoprol |
| CN1370540A (en) * | 2001-02-15 | 2002-09-25 | 暨南大学 | Medicine for treating maligant leucoma and its compounding process |
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2001
- 2001-03-15 CN CNB011041110A patent/CN1332672C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285743A (en) * | 1997-11-10 | 2001-02-28 | 斯隆－凯特林纪念癌症中心 | Process for production of arsenic trioxide formulations and methods for treating cancer using arsenic troxide or melarsoprol |
| CN1370540A (en) * | 2001-02-15 | 2002-09-25 | 暨南大学 | Medicine for treating maligant leucoma and its compounding process |
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| Publication number | Publication date |
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| CN1375294A (en) | 2002-10-23 |
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